NCT07330752

First-in-Human Trial of the A3-Shield System for Stabilizing Abdominal Aortic Aneurysms

PRemarket INvestigation to Evaluate the Clinical Safety and effectIveness of the Protective "A3- Shield" System for the stabIlIzation of Abdominal Aortic aneurysmS - Pilot Phase

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Angiolutions GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This clinical trial evaluates the safety and feasibility of the A3-Shield implant for stabilising small abdominal aortic aneurysms in adult patients. The study enrolls men and women with small, asymptomatic infrarenal abdominal aortic aneurysms who are eligible for an elective catheter-based procedure. The trial aims to determine whether implantation of the A3-Shield device is technically feasible and whether it is associated with mechanical immobilization of the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device. Participants will undergo implantation of the A3-Shield device and attend scheduled follow-up visits that include clinical assessments and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group.

Detailed description

Current management of abdominal aortic aneurysms is severely limited by the lack of therapeutic options that can halt the underlying dilating biology. At present, there is no available intervention that can sufficiently intercept the size progression of small abdominal aortic aneurysms. This gap is highly relevant because the vast majority of abdominal aortic aneurysms are detected at a small size, and a substantial proportion of these aneurysms enlarge over the following years and eventually require prosthetic repair, which carries procedure-related and long-term risks. The limited efficacy of endovascular aortic repair in small aneurysms and the significant long-term complications observed in large aneurysms treated by endovascular aortic repair are thought to be related, at least in part, to insufficient control of aneurysm sac expansion. Effective stabilisation of aneurysm size at an early stage therefore represents a major unmet need in abdominal aortic aneurysm management. The A3-Shield implant introduces a new approach to aneurysm treatment by targeting the biomechanical forces that contribute to aneurysm enlargement. Each heartbeat generates aortic pulse waves that propagate along the vessel and induce pulsatile wall motion. As these pulse waves reach the aneurysmal segment, they generate concentrated mechanical stress at the AAA shoulder region. This stress concentration is believed to promote further expansion of the aneurysm. The A3-Shield implant is designed to counteract this mechanism by mechanically immobilizing the aneurysm neck and gradually dampening the transmission of harmful pulse wave forces into the aneurysm sac, thereby aiming to protect the aneurysm from stress-induced enlargement. This first-in-human clinical trial evaluates the safety and feasibility of the A3-Shield implant in adult patients with small infrarenal abdominal aortic aneurysms. The primary objectives are to determine whether the implantation procedure is technically feasible and whether it is associated with suppression of pulse wave transmission at the aneurysm neck. The study also assesses the peri-procedural and safety profile of the device. Participants undergo a catheter-based implantation of the A3-Shield device under fluoroscopic guidance. Following the procedure, they attend scheduled follow-up visits that include clinical examinations and imaging such as ultrasound and computed tomography. The study does not include randomisation or a separate control group. The findings from this pilot phase are intended to support further clinical development and may provide early evidence for a new interventional strategy that addresses an unmet need in the management of small abdominal aortic aneurysms.

Conditions

• Aneurysm, Abdominal Aortic

Interventions

Type	Name	Description
DEVICE	A3-Shield Implantation	Implantation of the A3-Shield Device in the AAA Neck

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-07-01
• Completion: 2028-07-01
• First posted: 2026-01-09
• Last updated: 2026-01-09

Locations

1 site across 1 country: Uzbekistan